The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1).

Proportion of patients achieving undetectable HCV RNA at the actual end of treatment [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]

Proportion of patients having undetectable HCV RNA levels at the actual end of treatment (ie, Week 24, Week 48, or early discontinuation).

Proportion of patients achieving less than 25 IU/mL [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]

Proportion of patients having less than 25 IU/mL at the planned end of treatment (ie, Week 24 or Week 48).

Proportion of patients with on-treatment virologic failure [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]

Proportion of patients with on-treatment virologic failure (an increase greater than 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA greater than 100 IU/mL in patients whose HCV RNA has previously become less than 25 IU/mL during treatment).

Proportion of patients who relapse (having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA levels (less than 25 IU/mL, undetectable) at planned end of treatment.

All patients who will receive 12 weeks of treatment with telaprevir 750 mg q8h except for patients on efavirenz will receive 1125 mg every 8 hours (q8h) in combination with Pegylated-Interferon-alfa-2a (Peg-IFN-alfa-2a) 180 μg/week and RBV 800 mg/day. At Week 12, telaprevir dosing will end and the patients will continue on Peg-IFN-alfa-2a and RBV.

Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy.

Detailed Description:

This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in HCV treatment-naive and treatment-experienced patients infected with both chronic HCV-1 and HIV-1 to determine the efficacy and safety of telaprevir given with Peg-IFN-alfa-2a and RBV. The study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior HCV treatment status, liver disease status, and individual on-treatment virologic response in this study (equal response guided therapy). The maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included). Approximately 150 patients infected with both chronic HCV-1 and HIV-1 are planned to be enrolled.

Confirmed diagnosis of HIV-1 infection greater than 6 months before the screening visit

CD4 count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3 within 6 months of screening visit

HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the screening visit

No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit

Currently taking one of the permitted anti-HIV regimens for greater than or equal to12 weeks

Exclusion Criteria:

Anticipated need to switch anti-HIV regimen from screening through the Telaprevir treatment period

Infection or co-infection with HCV other than genotype 1

Contraindication to the administration of Peg-IFN-alfa or RBV

Hepatitis B virus (HBV) co-infection

Acute or active condition of HIV-associated opportunistic infection within 6 months of screening

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01513941